Zyderm® & Zyplast®
Zyderm® and Zyplast® Injectable Collagen Implants
What are Zyderm® and Zyplast collagen® implants?
Introduced in 1981, Zyderm® and Zyplast collagen® implants are a fast, safe, nonsurgical way to reduce the appearance of facial lines and wrinkles. The procedure is performed in the doctor’s office-this means there’s no hospital stay required. Specifically, you can smooth facial lines, wrinkles and scars, and also enhance the lip border in just one treatment session, and see immediate, visible results!
How do Zyderm® and Zyplast collagen® implants work?
Zyderm® and Zyplast collagen® implants replenish the skin’s natural collagen support layer, smoothing facial lines and most types of scars. The treatment can also enhance the appearance of the lip border. Zyderm® and Zyplast collagen® implants are natural substances derived from highly purified bovine (cow) collagen that are injected just beneath the skin’s surface, where the body commonly accepts them as its own. Treatment with Zyderm® or Zyplast collagen® implants produces an immediately visible difference in the appearance of your skin.
What can I expect from my treatment?
With Zyderm® and Zyplast collagen® implants, most patients notice a softening of facial lines, wrinkles, and scars, or a more defined lip border, in just one treatment session.While healing time varies, many people have the procedure and return to work that same day. The results of treatment usually last from 3 to 6 months. Just like natural collagen, injectable collagen eventually breaks down.So ongoing treatments are necessary to maintain the results you desire. If treatments with Zyderm® and Zyplast® implants are discontinued altogether, the injected collagen is simply reabsorbed by your body over time, and your face gradually returns to its natural contours.You and your doctor will customize a treatment program to meet your individual needs. No matter which treatment option you choose, be sure you receive the amount of collagen necessary to achieve the look that’s right for you.
What makes Zyderm® and Zyplast collagen® implants unique?Zyderm® and Zyplast collagen® implants are:
- The only injectable collagen products to undergo rigorous clinical studies in 5,000 patients
- The only injectable collagen products used for 20 years in over 1 million people worldwide
- The only injectable collagen products to be subjected to the Food and Drug Administration’s strict device approval process, and be cleared for marketing
- The only products of their kind that include lidocaine, a numbing agent, to help ensure your comfort
How affordable are treatments with Zyderm® and Zyplast collagen® implants?
Zyderm® and Zyplast collagen® treatments are as affordable as a couple of visits to the salon, a few rounds of golf, or a new outfit. Each of these activities has the same thing in common … it helps you look better, and feel better.
Prices may vary based on the number of areas of the face treated, and the amount of collagen required. Your doctor may offer programs to help make your treatment more affordable. Be sure to ask your doctor about these special programs.
How do I get started?
Before treatment, a simple skin test is performed on your forearm to determine if you are sensitive to Zyderm® or Zyplast collagen® implants. You will be asked to watch this area carefully over a 4-week period. Approximately 97% of women and men tested show no reaction to the skin test and are eligible for treatment.
Most patients have great success with their Zyderm® and Zyplast collagen® treatments, and experience no adverse events. However, as with any medical procedure, there are some risks. Be sure to read the safety summary at the end of this brochure, and to discuss the benefits and risks with your physician.
Zyderm Collagen® and Zyplast Collagen® Implants are available. Made of highly purified bovine collagen, these materials can be injected into your skin to supplement your body’s own collagen and actually fill certain lines and facial furrows.
How does Zyderm Collagen® differ from Zyplast Collagen®?
Zyderm Collagen® was formulated especially for people with small or superficial contour problems. It can be particularly effective in smoothing delicate frown and smile lines, as well as the fine creases that develop at the corners of the eyes and above and below the lips. It can also help correct certain kinds of shallow scars.
Zyplast Collagen® was designed to treat depressions requiring a stronger material. It is used for more pronounced contour problems (such as deeper scars, lines, and furrows) and for areas upon which more force is being exerted (such as the corners of the mouth).
Zyderm® and Zyplast Collagen® Implants may be used alone or in conjunction with one another. Your physician will determine the potential benefits of each, and an appropriate course of treatment.
Can anyone be treated with Zyderm Collagen® or Zyplast Collagen® Implants?
No. Your doctor will inquire about your medical history and administer a skin test to determine if you are an appropriate candidate for treatment. If you have a history of allergy to other bovine (cow) collagen products, severe allergies (indicated by a history of anaphylaxis [shock], or a history of multiple severe allergies), if you are currently on corticosteroid or immunosuppressive therapy, e.g., prednisone, or are undergoing or planning to undergo desensitization injections to meat products, you cannot receive injectable collagen. Also, people who are sensitive to lidocaine cannot receive collagen implants, as a small amount of this anesthetic is contained in Zyderm® and Zyplast Collagen® Implants, and in the Collagen Test Implant. Furthermore, people who have had a previous allergic reaction to either Zyderm® or Zyplast Collagen® may not be re-treated. Neither Zyderm® nor Zyplast Collagen® Implant should be used for breast augmentation, and neither material should be injected into bone, tendon, ligament or muscle.
If you have a personal history of autoimmune disease which includes (but is not limited to) rheumatoid arthritis, psoriatic arthritis, scleroderma (including CREST syndrome), systemic or discoid lupus erythematosus, or polymyositis, a dietary allergy to beet, your doctor may want to administer additional skin tests before deciding if you should be treated.
If you have any questions about these medical conditions, be sure to discuss them with your doctor. You will also be skin tested prior to treatment. Anyone who exhibits a sensitivity to the material, as demonstrated by the skin test, cannot proceed with treatment.
What is involved in injectable collagen treatment?
There are three steps: a skin test, the treatment series, and periodic touch-ups.
How does the skin test work?
To determine if you are eligible for treatment with either Zyderm® or Zyplast Collagen® Implant, your doctor will inject a small amount of collagen into your forearm, just below the skin’s surface. Both you and your doctor should watch the test site closely for four weeks for any signs of sensitivity to the material such as redness, swelling, or itching. Pay special attention to our test site during the first three days since the majority of test reactions occur during this period. At the first sign of any of these problems, contact your doctor.
Only about three out of every 100 tested patients show a sensitivity to the test and cannot be treated with injectable collagen; 97 percent of all tested patients can be treated.
When does treatment start?
Treatment can begin after the four-week test observation period if you are not sensitive to the skin test. Treatment involves a series of office visits -usually two weeks apart. Most patients see considerable improvement in one to three treatment sessions depending on the size, shape, and texture of the area undergoing treatment.
Do the injections hurt?
You may find that the injections are somewhat uncomfortable, particularly around the nose or lips. However, both Zyderm® and Zyplast Collagen® Implants contain a small amount of lidocaine that helps numb the area temporarily, and most people report that the injections are relatively painless.
How will my skin look and feel immediately after treatment?
Most patients feel comfortable in resuming their normal activities following treatment. Temporary puffiness of the treated areas, however, should be expected, especially with Zyderm Collagen® Implant.
With both Zyderm® and Zyplast Collagen® Implants, you may also notice temporary blushing, slight bruising, and tenderness around the treatment sites. Like the puffiness, these are normal occurrences and all should subside within a few days. Although the material is generally not visibly distinguishable from the surrounding skin, some patients have reported that they were initially able to feel the outline of the injected collagen.
However, as the new collagen is incorporated into your own skin, the treatment site takes on the natural look and feel of healthy skin. Any redness and/or visible swelling that persists for more than a few days may indicate a reaction to the material. Be sure to report this or any other questionable symptoms to your doctor.
How common are treatment reactions?
With more than 500,000 people treated to date, only a small number of patients (approximately 1-2 percent) have developed an allergic reaction after one or more treatment injections. These reactions may consist of prolonged redness, swelling, itching and/or firmness at some or all injection sites. Most have lasted between three and four months, but some have exceeded one year.
In less than 1% of treated patients, formation of a scab and sloughing (shedding) of the tissue at the treatment site have been noted, which can result in a shallow scar. On rare occasions, abscess formation has occurred at implantation sites. These reactions develop weeks to months following injections, and may result in induration and/or scar formation.
Also, in fewer than 3 per 1000 treated patients, the following have been reported: systemic complaints such as flu-like symptoms (nausea, fever, dizziness, headache, malaise, joint aches), rash, blurred vision, tingling, numbness or difficulty in breathing.
Of the patients who have developed an allergic reaction after treatment, 50% had an unreported or unrecognized response to the skin test. With proper monitoring of the skin test, many of these reactions could have been prevented. The remaining 50% of this group developed allergic reactions despite a response-free skin test.
An additional one percent of individuals experience symptoms similar to those of an allergic reaction that may, however, occur periodically. Recent research has shown that some of these patients are allergic to bovine collagen.
If you observe any symptoms such as redness and/or swelling, please inform your physician. He or she will determine if you should discontinue treatment; no further injectable collagen can be administered to anyone who has experienced an allergic reaction to the material.
Are there any other types of reactions I should be aware of?
Yes. There is a possibility that you could experience a reaction related to the injection process itself. However, this does not mean it is necessary to discontinue treatment. For instance, mild bruising or a slight blush could occur at the injection site. If you have previously had facial herpes simplex at the site of injection, there is a chance that the injection process itself could provoke another herpes simplex eruption. It you are using aspirin or non-steroidal anti-inflammatory drugs that reduce coagulation, you may experience increased bruising or bleeding at injection sites. In addition, any injection carries a small risk of infection.
Some physicians have reported the occurrence of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis (PM) and dermatomyosilis (DM) subsequent to collagen injections, in patients with no previous history of these disorders. Conflicting studies have been published in scientific journals regarding the association between PM/DM and injectable collagen. A causal (cause and effect) relationship between collagen injections and the onset of PM/DM, or the other connective tissue diseases listed, has not been established.
Also, an increased incidence of cell-mediated and humoral immunity to various collagens have been found in systemic connective tissue diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, and progressive systemic sclerosis (scleroderma). Patients with these diseases may thus have an increased susceptibility to an allergic response and/or accelerated clearance of their implants when injected with bovine dermal collagen preparations. If you have any of these diseases, you should discuss this specifically with your doctor.
It is possible that, during the process of administering injectable collagen, the needle could be accidentally placed into or through a blood vessel. This has been reported to have occurred in less than 1% of patients treated. However, if it should happen, it could result in temporary discoloration of the treated area and/or formation of a scab, and sloughing (shedding) of this tissue at the treatment site can result in a shallow scar. Also, as with other substances that are injected (particularly local anesthetics and steroids injected into the head and neck area or the extremities), there is a remote possibility of accidental injection of the material into a blood vessel. This could result in blockage of the blood flow and loss of circulation to nearby sites, which in one case resulted in permanent loss of vision in one eye.
There have been infrequent reports of the injected collagen being visible in the skin, in the form of a small raised or white area at the treatment site, which may persist from a few weeks to several months. Also, some areas (such as compressed scars) resist precise placement of the material, resulting in a slight elevation beside the defect.
An understanding of the safety of injectable collagen is based on clinical data from 1978 to the present. Ongoing research will continue to provide more information.
Does the correction last forever?
No. Touch-up injections are usually needed to maintain maximum correction. Because both Zyderm® and Zyplast Collagen® Implants are similar to your own skin, they will be altered by the same ongoing mechanical forces such as smiling or other muscle activity and biochemical processes – such as aging and active acne – that caused the original skin depressions. It has been reported that the body may deposit its own collagen at the site of collagen implantation. You should therefore be aware that part or all of the correction may last for 2 years or longer.
How often will I need a “touch-up” injection?
Most patients who choose to receive touch-ups for lines or furrows do so within 3 to 12 months of the original treatment series. For scars, and perhaps those depressions treated with Zyplast Collagen®, the time between touch-ups may be longer. But keep in mind that the amount of collagen used to restore full correction will be considerably less than that used in the initial treatment series.
Use of Zyderm/Collagen® Implant in an individual patient should be limited to 30 cc over a one-year period. Use of Zyderm II Collagen® Implant in an individual patient should be limited to 15 cc over a one-year period. The combination of these products or of Zyderm® in conjunction with Zyplast® in an individual patient should be limited to 30 cc over a one-year period. The safety of injecting greater amounts on an annual basis has not been established.
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